Aseptic connector with deflectable ring of concern and method

ABSTRACT

An aseptic fluid connector having a first connector including a first fluid passageway for receiving a fluid therein; a first port in fluid communication with the first fluid passageway for passage of the fluid therethrough; and a first deflecting member. The first deflecting member includes a first engaging portion radially spaced relative to the first port, and a first valve movable between a closed position and an open position with movement of the first engaging portion between a non-deflected position and a deflected position, respectively. In the non-deflected position, the first valve is located in the closed position forming a fluid-tight seal between the first valve and first port and preventing the passage of fluid therethrough, and in the deflected position, the first valve is located in the open position allowing the aseptic passage of fluid through the first port.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application claims benefit pursuant to 35 U.S.C. §119(e) ofU.S. Provisional Application Ser. No. 61/320,857, filed Apr. 5, 2010,the contents of all of which are hereby expressly incorporated byreference in their entireties as part of the present disclosure.

FIELD OF THE INVENTION

The present invention relates to fluid connectors and methods oftransferring fluids, and more particularly, relates to aseptic fluidconnectors and methods for aseptically transferring fluids.

BACKGROUND INFORMATION

A typical fluid connector includes a male connector that is receivedwithin a female connector to place the two connectors in fluidcommunication with each other. The male and female connectors may bethreadedly engaged, snap fit, or otherwise releasably connected to eachother to allow for interconnection and disconnection. Each connector iscoupled in fluid communication with a respective fluid passageway, suchas a tube or fluid chamber, in order to place the fluid passageways influid communication with each other and allow the passage of fluidstherebetween.

Such fluid connectors typically do not prevent the contamination offluids passing through them. For example, prior to interconnection ofthe male and female connectors, the fluid-contacting surfaces thereofcan be exposed to the ambient atmosphere and contaminated throughcontact with airborne germs and/or by contact with contaminatedsurfaces. One approach to preventing such contamination is to wipe thefluid-contacting surfaces of the male and female connectors with analcohol wipe or other disinfectant prior to interconnection. Onedrawback of this approach is that it may not remove all germs on thefluid-contacting surfaces. Another drawback of this approach is that thefluid-contacting surfaces may become contaminated after the wipe isapplied but prior to interconnection of the male and female connectors.Yet another drawback of this approach is that it can be time consumingand considered a nuisance, and therefore unreliable in practice.

Accordingly, aseptic or sterile fluids can be subjected to contaminationwhen passed through such prior art connectors. Such contamination cangive rise to significant problems. If used in a hospital or othermedical facility, such as to transfer sterile drugs or other fluidsintended for intravenous injection, for example, any such contaminationcan lead to viral and other types of infections, serious illnesses, anddeath. In food processing applications, on the other hand, it may benecessary to connect fluid conduits, for example, in order to transfersterile or aseptic fluids from one passageway to another. If the fluidsare contaminated upon passage through a fluid connector, this can leadto contamination of previously-sterile food products, and if suchcontaminated products are ingested, they can cause infections and/orillnesses. In industrial applications, it may be necessary to prevent atoxic fluid passing through a connector from contaminating the ambientatmosphere, an operator handling the connector, and/or other surfacesthat might be located external to the connector. If the fluid-contactingsurfaces of the connector are exposed to human contact, or surfaces thatcome into human contact, for example, this can lead to possible injuryand/or illnesses.

Accordingly, it is an object of the present invention to overcome one ormore of the above-described drawbacks and/or disadvantages of the priorart.

SUMMARY OF THE INVENTION

In accordance with a first aspect, the present invention is directed toan aseptic fluid connector comprising a first connector including afirst fluid passageway for receiving a fluid therein; a first port influid communication with the first fluid passageway for passage of thefluid therethrough; and a first deflecting member. The first deflectingmember includes a first engaging portion radially spaced relative to thefirst port, and a first valve movable between a closed position and anopen position with movement of the first engaging portion between asubstantially non-deflected position and a deflected position,respectively. In the substantially non-deflected position, the firstvalve is located in the closed position forming a fluid-tight sealbetween the first valve and first port and preventing the passage offluid therethrough, and in the deflected position, the first valve islocated in the open position allowing the aseptic passage of fluidthrough the first port.

In the currently preferred embodiments of the present invention, theaseptic connector further includes a second connector connectable to thefirst connector. The second connector includes a second fluid passagewayfor receiving a fluid therein; a second port in fluid communication withthe second fluid passageway for passage of the fluid therethrough; and asecond deflecting member. The second deflecting member includes a secondengaging portion radially spaced relative to the second port, and asecond valve movable between a closed position and an open position withmovement of the second engaging portion between a substantiallynon-deflected position and a deflected position, respectively. In thesubstantially non-deflected position, the second valve is located in theclosed position forming a fluid-tight seal between the second valve andsecond port and preventing the passage of fluid therethrough, and in thedeflected position, the second valve is located in the open positionallowing the passage of fluid through the second port.

In currently preferred embodiments of the present invention, the firstand second connectors are movable between non-connected and connectedpositions. In the non-connected position, the first and second engagingportions are in their substantially non-deflected positions, and thefirst and second valves are in their closed positions. In such position,each valve forms a fluid-tight seal between the respective port andambient atmosphere and prevents external contamination of anyfluid-contacting surfaces of the respective port. In the connectedposition, on the other hand, the first and second engaging portions arein the deflected position and the first and second valves are in theopen position to allow sterile fluid flow therebetween.

In currently preferred embodiments of the present invention, eachconnector further includes a body defining a sealing surface formedadjacent to the respective port, and engageable with the respectivevalve in the closed position to form a fluid-tight seal between thevalve and port. In some such embodiments, each sealing surface issubstantially annular, each valve is substantially annular, and in theclosed position, each valve engages the respective sealing surface andforms an annular fluid-tight seal therebetween. In some suchembodiments, each sealing surface is relatively rigid and each valve isflexible. In the closed position, each valve and respective sealingsurface form an interference fit therebetween at the annular fluid-tightseal. In some such embodiments, each engaging portion is formed integralwith the respective valve, is radially spaced relative to the respectivevalve, extends annularly about the respective valve, and extends axiallyrelative to the respective valve. Preferably, each engaging portion andvalve are made of an elastic material, such as silicone.

In the currently preferred embodiments of the present invention, thefirst connector further includes a first body defining a first sealingsurface formed adjacent to the first port, and engageable with the firstvalve in the closed position to form a fluid-tight seal between thefirst valve and first port. The second connector further includes asecond body defining a second sealing surface formed adjacent to thesecond port, and engageable with the second valve in the closed positionto form a fluid-tight seal between the second valve and second port. Insome such embodiments, in the non-deflected position, the first valveforms a fluid-tight seal between the first port and ambient atmosphereand prevents external contamination of any fluid-contacting surfaces ofthe first port. Similarly, the second valve forms a fluid-tight sealbetween the second port and ambient atmosphere, and prevents externalcontamination of any fluid-contacting surfaces of the second port. Insome such embodiments, the first sealing surface is substantiallyannular, the first valve is substantially annular, and in the closedposition, the first valve engages the first sealing surface and forms anannular fluid-tight seal therebetween. Similarly, the second sealingsurface is substantially annular, the second valve is substantiallyannular, and in the closed position, the second valve engages the secondsealing surface and forms an annular fluid-tight seal therebetween. Inthe currently preferred embodiments, each annular fluid-tight sealextends axially between the respective valve and sealing surface tofurther prevent the ingress of contaminants through the seal.

Also in the currently preferred embodiments of the present invention,the first sealing surface is relatively rigid, the first valve isflexible, and in the closed position, the first valve and first sealingsurface form an interference fit therebetween at the respective annularfluid-tight seal. Similarly, the second sealing surface is relativelyrigid, the second valve is flexible, and in the closed position, thesecond valve and second sealing surface form an interference fittherebetween at the respective annular fluid-tight seal. In some suchembodiments, the first engaging portion is formed integral with thefirst valve, is radially spaced relative to the first valve, extendsannularly about the first valve, and extends axially relative to thefirst valve. Similarly, the second engaging portion is formed integralwith the second valve, is radially spaced relative to the second valve,extends annularly about the second valve, and extends axially relativeto the second valve. In some such embodiments, each deflecting portionis substantially dome shaped, and each valve extends laterally withrespect to the axis of the respective dome-shaped deflecting portion. Insome such embodiments, each deflecting portion is substantiallycylindrical shaped, and each valve extends substantially normal to anaxis of the respective substantially cylindrical shaped deflectingportion. Preferably, the first engaging portion and first valve are madeof an elastic material, such as silicone, and the second engagingportion and second valve are made of an elastic material, such assilicone.

In the currently preferred embodiments of the present invention, in theconnected position, the first and second engaging portions engage eachother and deflect each other into the deflected positions, and the firstand second valves are invaginated within the first and second engagingportions into their respective open positions, the first and secondports are in fluid communication with each other, and fluid is permit toflow therebetween.

In the currently preferred embodiments of the present invention, in theconnected position, the first and second engaging portions form asubstantially fluid-tight seal therebetween. In some such embodiments,in the connected position, the first and second engaging portions extendannularly about the first and second valves and the first and secondports, respectively, and form a substantially fluid-tight seal withrespect to ambient atmosphere. In some such embodiments, in theconnected position, the first and second valves extend annularly aboutthe first and second ports, respectively, form a substantiallyfluid-tight seal with respect to ambient atmosphere, and preventcontamination of any fluid-contacting surfaces of the first and secondports.

In some embodiments of the present invention, the first connector is afemale connector, and the second connector is male connector that isreceived within the female connector in the connected position. In somesuch embodiments, the first connector includes a first connector housingthat extends annularly about the first engaging portion and the firstvalve and extends axially outwardly therefrom. Similarly, the secondconnector includes a second connector housing that extends annularlyabout the second engaging portion and the second valve, and extendsaxially outwardly therefrom, and is receivable within the firstconnector housing in the connected position. In the connected position,the second connector housing is received within the first connectorhousing, and the first and second engaging portions and the first andsecond valves, are located within the second connector housing. In somesuch embodiments, the first connector includes a first body defining thefirst port, the second connector includes a second body defining thesecond port, and in the closed position, a distal portion of the secondbody is received within a distal portion of the first body.

In some embodiments of the present invention, the first connectorincludes a plurality of first ports angularly spaced relative to eachother, and the second connector includes a plurality of second portsangularly spaced relative to each other. In some embodiments of thepresent invention, a first fluid conduit is connected in fluidcommunication with the first connector, and a second fluid conduit isconnected in fluid communication with the second connector.

In accordance with another aspect, the present invention is direct to anaseptic connector comprising first means for connecting. The first meansincludes a first fluid passageway for receiving a fluid therein; secondmeans in fluid communication with the first fluid passageway for thepassage of the fluid therethrough; and third means for deflecting. Thethird means includes fourth means radially spaced relative to the secondmeans for engaging another connector and for deflecting the third means,and fifth means movable between (i) a closed position for sealing thesecond means by forming a fluid-tight seal between the fifth means andsecond means and for preventing the passage of fluid therethrough, and(ii) an open position for allowing fluid flow through the second means.The fifth means is movable between the closed and open positions withmovement of the fourth means between the substantially non-deflectedposition and a deflected position, respectively.

In some embodiments of the present invention, the aseptic connectorfurther comprises sixth means for connecting. The sixth means includes asecond fluid passageway for receiving a fluid therein; seventh means influid communication with the second fluid passageway for passage of thefluid therethrough; and eighth means for deflecting. The eighth meansincludes ninth means radially spaced relative to the seventh means forengaging another connector and deflecting the eighth means, and tenthmeans movable between (i) a closed position for sealing the seventhmeans by forming a fluid-tight seal between the tenth means and seventhmeans and for preventing the passage of fluid therethrough, and (ii) anopen position for allowing fluid flow through the seventh means. Thetenth means is movable between the closed and open positions withmovement of the ninth means between the substantially non-deflectedposition and a deflected position, respectively.

In the currently preferred embodiments of the present invention, thefirst means is a first connector, the second means is a first port, thethird means is a first deflecting member, the fourth means is a firstengaging portion, the fifth means is a first valve, the sixth means is asecond connector, the seventh means is a second port, the eighth meansis a second deflecting member, the ninth means is a second engagingportion, and the tenth means is a second valve.

In accordance with another aspect, the present invention is directed toa method comprising the following steps:

providing a first connector including a first valve hermetically sealingin a normally closed position a first port in fluid communication with afirst fluid passageway, and a sterile fluid in fluid communication withthe first fluid passageway;

connecting the first connector to a second connector including a secondport in fluid communication with a second fluid passageway;

during the connecting step, deflecting the first valve from the normallyclosed position to an open position, and placing the first port in fluidcommunication with the second port;

allowing a flow of sterile fluid through the first and second ports; and

during the preceding steps, maintaining the first and second portshermetically sealed with respect to ambient atmosphere and therebypreventing contamination of any fluid-contacting surfaces of the firstand second ports and of the sterile fluid flowing therethrough.

In some embodiments of the present invention, the first connectorincludes a first valve and a first deflecting member, and the secondconnector includes a second valve and a second deflecting member. Thedeflecting step includes placing the first and/or second deflectingmembers into engagement with the other, deflecting the first and seconddeflecting members and, in turn, moving the first and second valves fromnormally closed positions to open positions and, in turn, placing thefirst and second ports in fluid communication with each other.

In some such embodiments, the method further comprises the step offorming a fluid tight seal between (i) the first and second deflectingmembers, and/or (ii) the first and second valves, when in the connectedand open positions, to hermetically seal the first and second ports withrespect to ambient atmosphere, and thereby prevent contamination of anyfluid-contacting surfaces of the first and second ports and of thesterile fluid flowing therethrough.

In some such embodiments, during the connecting step, the first andsecond deflecting members resiliently engage each other, and invaginatethe first and second valves into the open position and into contact witheach other to form an annular, fluid-tight seal therebetween.

One advantage of the present invention is that when not connected, thevalve maintains the port hermetically sealed with respect to ambientatmosphere and prevents contamination of any fluid-contacting surfacesconnector. Then, when connected, the valve and/or deflecting membermaintains the port and any fluid-contacting surfaces hermetically sealedwith respect to ambient atmosphere. Accordingly, the present inventionis particularly advantages for fluid transfer of aseptic or sterilefluids. For example, two fluid conduits can be interconnected with theconnector of the present invention, and an aseptic or sterile fluidpassed therethrough, without contaminating the aseptic or sterile fluid.

Other objects and advantages of the present invention, and/or of thecurrently preferred embodiments thereof, will become more readilyapparent in view of the following detailed description of the currentlypreferred embodiments and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective, cross-sectional view of a connector embodyingthe present invention showing the male and female connectors in anon-connected state with the valves of the connectors in their closedpositions hermetically sealing the interiors of the connectors fromambient atmosphere;

FIG. 2A is a perspective, cross-sectional view of the connector of FIG.1 showing the start of an interconnection of the male and femaleconnectors wherein the male connector housing is initially receivedwithin the female connector housing and the engaging surfaces of theopposing deflecting members are in peripheral contact with each other;

FIG. 2B is a perspective, cross-sectional view of the connector of FIG.2A showing progression of the interconnection of the male and femaleconnectors wherein the opposing deflecting members are further pressedinto engagement with each other forming an annular fluid-tight sealtherebetween, and the valves are initially deflected away from therespective sealing surfaces to initiate opening of the valves;

FIG. 2C is a perspective, cross-sectional view of the connector of FIG.2B showing further progression of the interconnection of the male andfemale connectors, wherein the deflecting members are further deflectedinto engagement with each other, the valves are further moved radiallyaway from the respective sealing surfaces to further open the sterileflow path between the ports of the male and female connectors;

FIG. 2D is a perspective, cross-sectional view of the connector of FIG.2C showing further progression of the interconnection of the male andfemale connectors, wherein the opposing valves of the connectors aredeflected or invaginated into contact with each other to initiateforming a fluid-tight seal therebetween and to further open the sterileflow path between the ports of the connectors;

FIG. 2E is a perspective, cross-sectional view of the connector of FIG.2D showing further progression of the interconnection of the male andfemale connectors, wherein both the opposing deflecting members andopposing valves of the connectors are pressed into full engagement witheach other to form annular fluid-tight seals therebetween and to furtheropen the sterile flow path between ports of the connectors;

FIG. 3 is a perspective, cross-sectional view of the connector of FIG.2E showing full interconnection of the male and female connectors,wherein an annular fluid-tight seal is formed between the opposingvalves of the connectors to seal the sterile fluid flow path between theports of the connectors, and the ring of concern within thesubstantially cylindrical deflecting members is sealed with respect tothe sterile fluid flow path to prevent any contamination of the sterilefluid flow path or the fluid flowing through the connector;

FIG. 4A is a cross-sectional view of another embodiment of a connectorof the present invention showing the male and female connectors in anon-connected state with the valves of the connectors in their closedpositions hermetically sealing the interiors of the connectors fromambient atmosphere, the connector further having a pair of supportscoupled to the male and female connectors for enhanced durability; and

FIG. 4B is a cross-sectional view of the connector of FIG. 4A showingfull interconnection of the male and female connectors, wherein anannular fluid-tight seal is formed between the opposing valves of theconnectors to seal the sterile fluid flow path between the ports of theconnectors, and the ring of concern within the substantially cylindricaldeflecting members is sealed with respect to the sterile fluid flow pathto prevent any contamination of the sterile fluid flow path or the fluidflowing through the connector.

DETAILED DESCRIPTION OF THE CURRENTLY PREFERRED EMBODIMENTS

In FIG. 1, a connector embodying the present invention is indicatedgenerally by the reference numeral 10. The connector 10 comprises afirst or female connector 12 including a first fluid passageway 14 forreceiving a fluid therein; a plurality of first ports 16 in fluidcommunication with the first fluid passageway 14 for passage of thefluid therethrough; and a first deflecting member 18. The firstdeflecting member 18 includes a first engaging portion 20 radiallyspaced relative to the first port 16, and a first valve 22 movablebetween a closed position (FIG. 1) and an open position (FIG. 3) withmovement of the first engaging portion 20 between a substantiallynon-deflected position (FIG. 1) and a fully deflected position (FIG. 3),respectively. In the substantially non-deflected position (FIG. 1), thefirst valve 22 is located in the closed position forming a fluid-tightseal between the first valve and first ports 16 and preventing thepassage of fluid therethrough. In the fully deflected position (FIG. 3),the first valve 22 is located in the fully open position allowing theaseptic passage of fluid through the first ports 16.

The aseptic connector 10 further includes a second or male connector 24connectable to the first or female connector 12. The second connector 24includes a second fluid passageway 26 for receiving a fluid therein; aplurality of second ports 28 in fluid communication with the secondfluid passageway 26 for the passage of the fluid therethrough; and asecond deflecting member 30. The second deflecting member 30 includes asecond engaging portion 32 radially spaced relative to the second ports28, and a second valve 34 movable between a closed position (FIG. 1) anda fully open position (FIG. 3) with movement of the second engagingportion 32 between a substantially non-deflected position (FIG. 1) and afully deflected position (FIG. 3), respectively. In the substantiallynon-deflected position (FIG. 1), the second valve 34 is located in theclosed position forming a fluid-tight seal between the second valve 34and second ports 28 and preventing the passage of fluid therethrough. Inthe fully deflected position (FIG. 3), the second valve 34 is located inthe fully open position allowing the passage of fluid through the secondports 28.

As shown in FIGS. 1 through 3, the first and second connectors 12, 24are movable into engagement with each between non-connected andconnected positions. In the non-connected position (FIG. 1), the firstand second engaging portions 20, 32 are in the substantiallynon-deflected positions, and the first and second valves 22, 34 are inthe closed positions. In the fully connected position (FIG. 3), thefirst and second engaging portions 20, 32 are engaged with each other inthe fully deflected positions, and the first and second valves 22, 34are in their fully open positions.

In the non-deflected position (FIG. 1), the first valve 12 forms afluid-tight seal 36 between the first ports 16 and ambient atmosphereand prevents external contamination of any fluid-contacting surfaces ofthe first ports 16. The first connector 12 further includes a first body38 defining a first sealing surface 40 formed adjacent to the firstports 16, and engageable with the first valve 22 in the closed positionto form a fluid-tight seal between the first valve and first ports. Ascan be seen, the first sealing surface 40 is substantially annular, thefirst valve 22 is substantially annular, and in the closed position, thefirst valve 22 engages the first sealing surface 40 and forms an annularfluid-tight seal 36 therebetween. The first sealing surface 40 isrelatively rigid and the first valve 22 is flexible. In the closedposition, the first valve 22 and first sealing surface 40 form aninterference fit therebetween at the annular fluid-tight seal 36. As canbe seen, the first engaging portion 20 is formed integral with the firstvalve 22, is radially spaced relative to the first valve 22, extendsannularly about the first valve 22, and extends axially relative to thefirst valve 22. The integral first engaging portion 20 and first valve22 are made of an elastic material, such as silicone.

In the non-deflected position (FIG. 1), the second valve 24 forms asecond fluid-tight seal 42 between the second ports 28 and ambientatmosphere, and prevents external contamination of any fluid-contactingsurfaces of the second ports 28. The second connector 24 furtherincludes a second body 44 defining a second sealing surface 46 formedadjacent to the second ports 28, and engageable with the second valve 34in the closed position to form a fluid-tight seal between the secondvalve and second ports. As can be seen, the second sealing surface 46 issubstantially annular, the second valve 34 is substantially annular, andin the closed position (FIG. 1), the second valve 34 engages the secondsealing surface 46 and forms an annular fluid-tight seal 42therebetween. The second sealing surface 46 is relatively rigid and thesecond valve 34 is flexible. In the closed position, the second valve 34and second sealing surface 46 form an interference fit therebetween atthe annular fluid-tight seal 42. As can be seen, the second engagingportion 32 is formed integral with the second valve 34, is radiallyspaced relative to the second valve 34, extends annularly about thesecond valve 34, and extends axially relative to the second valve 34.The integral second engaging portion 32 and second valve 34 are made ofan elastic material, such as silicone.

Each first engaging portion 20, 32 is formed integral with therespective valve 22, 34, is radially spaced relative to the respectivevalve, extends annularly about the respective valve, and extends axiallyrelative to the respective valve. In the illustrated embodiment, eachdeflecting portion 20, 32 is substantially dome shaped, and each valve22, 34 extends laterally with respect to the axis of the respectivedome-shaped deflecting portion. Also in the illustrated embodiment, eachdeflecting portion 20, 32 is substantially cylindrical shaped, and eachvalve 22, 34 extends substantially normal to an axis of the respectivesubstantially cylindrical-shaped deflecting portion. As indicated above,each engaging portion 20, 32 and integral valve 22, 34 are made of aflexible or elastic material, such as silicone.

It will be understood that the first and second integral valves 22, 34are formed of any suitable flexible or elastic material. In someembodiments, a suitable elastic material includes silicone, a vulcanizedlatex and/or a vulcanized rubber. In at least some embodiments, thefirst and second integral valves 22, 34 are formed of a material havinga substantially predetermined creep. Compression set measures theability of elastomeric materials to maintain elastic properties afterprolonged compressive stress and can be used as a measurement of thematerial's creep property. In some embodiments, the material for thefirst and second integral valves 22, 34 is selected from materialshaving a compression set value within the range of about 0% to about 50%(by ASTM D412), and preferably within the range of about 0% to about25%. In some embodiments, the integral valves 22, 34 form aninterference fit with sealing surfaces 40, 46 in the closed position. Inthe open position, the integral valves 22, 34 are deflected away fromsealing surfaces 40, 46. The integral valves 22, 34 are capable of beingmaintained in either the open or closed positions for substantialperiods of time. In some embodiments, the integral valves 22, 34 aremaintained in the open position for about 6, 12, 18, 24, 48 or 72 hours,and because of their relatively low creep property, they remain capableof sealingly engaging the sealing surfaces 40, 46 in the closed positionthereafter.

As shown in FIGS. 2E and 3, in the fully connected position, the firstand second engaging portions 20, 32 engage each other and deflect eachother into the deflected positions, and the first and second valves 22,34 are invaginated within the first and second engaging portions 20, 32into their fully open positions, the first and second ports 16, 28 arein fluid communication with each other, and as indicated by the brokenline arrows in FIG. 3, fluid is permitted to flow through a sterile flowpath therebetween that is hermetically sealed with respect to ambientatmosphere. In the fully connected position, the first and secondengaging portions 20, 32 form a substantially fluid-tight sealtherebetween. The first and second engaging portions 20, 32 extendannularly about the first and second valves 22, 34 and the first andsecond ports 16, 28, respectively, and form a substantially fluid-tightseal with respect to ambient atmosphere. Also in the fully connectedposition, the first and second valves 22, 34 extend annularly about thefirst and second ports 16, 28, respectively, are invaginated ordeflected into contact with each other to form a substantiallyfluid-tight seal therebetween and with respect to ambient atmosphere,and to prevent contamination of any fluid-contacting surfaces of thefirst and second ports when the valves are in the fully open position.As can be seen, any germs or other contaminants located on or within thedeflecting members 18, 30 (i.e., each deflecting member is a deflectingring of concern), are hermetically sealed within the engaged deflectingmembers, and thus prevented by the annular, fluid-tight seal between theengaged, opposing valve's 22, 34 from contacting any sterile fluidflowing through the connector.

The first or female connector 12 includes a first or female connectorhousing 48 that extends annularly about the first deflecting member 18and the first valve 22 and extends axially outwardly therefrom toenclose the respective deflecting member and valve. Similarly, thesecond or male connector 24 includes a second or male connector housing50 that extends annularly about the second deflecting member 30 and thesecond valve 34, and extends axially outwardly therefrom. As shown inFIGS. 2A through 3, the second or male connector housing 50 isreceivable within the first or female connector housing 48 tointerconnect and place the two connectors in fluid communication witheach other. In the connected positions, the second or male connectorhousing 50 is received within the first or female connector housing 48,and the first and second engaging portions 20, 32 and the first andsecond valves 22, 34, are located within the second or male connectorhousing 50. The first body 38 of the first connector 12 defines thefirst ports 16, and the second body 44 of the second connector 24defines the second ports 28. As shown in FIGS. 2E and 3, in the fullyclosed position, a distal portion 52 of the second body 44 is receivedwithin a distal portion 54 of the first body 38 to facilitate aligningthe first and second connectors and retaining them in the fully closedposition. As may be recognized by those of ordinary skill in thepertinent art based on the teachings herein, the first and secondconnectors 12, 24 can be releasably connected to each other in any ofnumerous different ways that are currently known, or that later becomeknown, such as by a threaded connection, snap fit, or other releasableinterconnection.

In the illustrated embodiment, the first connector 12 includes aplurality of first ports 16 angularly spaced relative to each other, andthe second connector 24 includes a plurality of second ports 28angularly spaced relative to each other. A first fluid conduit 56 isconnected in fluid communication with the first fluid passageway 14 ofthe first connector 12, and a second fluid conduit 58 is connected influid communication with the second fluid passageway 26 of the secondconnector 24. As may be recognized by those of ordinary skill in thepertinent basted on the teachings herein, the ports may take any ofnumerous different configurations that are currently known, or thatlater become known. For example, each connector may include only oneport, more than one port, and/or one connector may have a differentnumber and/or configuration of ports than the other connector. Forexample, one connector may have fewer angularly-elongated ports.Similarly, the first and second connectors may or may not be connectedto tubes as shown, but rather may be connected to any of numerousdifferent types of fluid sources, receptacles or devices that arecurrently known, or that later become known.

As shown in FIG. 1, in the non-connected, closed position, each annularfluid-tight seal 36, 42 extends axially between the respective valve 22,34 and sealing surface 40, 46 to further prevent the ingress ofcontaminants through the seal. Each sealing surface 40, 46 is relativelyrigid, each valve 22, 34 is flexible, and in the closed position, eachvalve 22, 34 and respective sealing surface 40, 46 form an interferencefit therebetween at the respective annular fluid-tight seal 36, 42.

As shown typically in FIG. 3, the first connector includes a firstaxially and annularly extending base 60 that overlies the first ports16. A first annular, deflectable joint 62 extends between the first base60 and first valve 22 to facilitate movement of the first valve 22between the closed and open positions. The first body 38 defines anannular and axially-extending first base surface 64 that is formedcontiguous to the first ports 16, and a first step 66 extending betweenthe base surface 64 and first sealing surface 40. In the illustratedembodiment, the first step 66 is oriented substantially normal the firstbase surface 64 and first sealing surface 40.

Similar to the first connector 12, and as shown typically in FIG. 3, thesecond connector 24 includes a second axially and annularly extendingbase 68 that overlies the second ports 28. A second annular, deflectablejoint 70 extends between the second base 68 and second valve 34 tofacilitate movement of the second valve 34 between the closed and openpositions. The second body 44 defines an annular and axially-extendingsecond base surface 72 that is formed contiguous to the second ports 28and a second step 74 extending between the base surface 72 and thesecond sealing surface 46. In the illustrated embodiment, the secondstep 74 is oriented substantially normal the second base surface 72 andsecond sealing surface 46.

In the closed position of the first connector 12 (FIG. 1), the firstbase 60 sealingly engages the first base 64 of the first valve body 38to form a fluid-tight seal therebetween, the first step 64 is receivedwithin, and sealingly engages the first step 66 of the first body 38 tofurther effectuate a fluid-tight seal, and the first valve 22 sealinglyengages the first sealing surface 40 to effectuate the fluid-tight sealbetween the valve and body. Similarly, in the closed position of thesecond connector 24, the second base 68 sealingly engages the secondbase 72 of the second valve body 44 to form a fluid-tight sealtherebetween, the second step 70 is received within, and sealinglyengages the second step 74 of the second body 44 to further effectuate afluid-tight seal, and the second valve 34 sealingly engages the secondsealing surface 46 to effectuate the fluid-tight seal between the valveand body. As can be seen, in the normally-closed position, all externalfluid-contacting surfaces of the first connector body 38 and secondconnector body 44 are hermetically sealed within the first and secondvalves 22 and 34, respectively. In the fully connected, open position,on the other hand (FIGS. 2E and 3), the valves 22, 34 are deflected orinvaginated into the fully open position into engagement with eachother, and thus moved radially away from the respective sealing surfaces40, 46, the deflecting joints 62, 70 are deflected radially away fromthe respective steps 64, 72, and the bases 60, 68 are deflected radiallyaway from the respective body base surfaces 64, 72, to thereby define anannulary, axially-extending fluid passageway 76 extending between thetwo connectors. As indicated by the broken line arrows in FIG. 3, in theconnected, fully open position, fluid is permitted to flow from thefirst fluid passageway 14, through the plurality of ports 16, throughthe annular, axially-extending passageway 76, through the plurality ofsecond ports 28, and into the second passageway 26. If desired, thefluid may flow in the opposite direction. The annular, axially-extendingpassageway 76 is hermetically sealed with respect to both thedeflectable ring of concern (i.e., the surfaces of the deflectingmembers 18, 30) and ambient atmosphere by abutting engagement of thefirst and second valves 22, 34. As can be seen, the fluid passingbetween the two connectors is maintained sealed with respect to ambientatmosphere, and the surfaces of the connectors that contact such fluidlikewise are sealed with respect to ambient atmosphere to therebymaintain the fluid sterile and hermetically sealed with respect toambient atmosphere.

Turning to FIG. 4A, another embodiment of a connector of the presentinvention is indicated generally by the reference numeral 110. Theconnector 110 is substantially the same as the connector 10 describedabove, and therefore like reference numerals preceded by the numeral “1”are used to indicate like elements. The primary difference of theconnector 110 in comparison to connector 10 is that it includes firstand second supports 180, 182 located between the bases of the first andsecond housings 148, 150 and the first and second valves 122, 134,respectively. The first and second supports 180, 182 may be molded withthe bases of the first and second integral valves 122, 134,respectively. In some embodiments, the first and second supports areco-molded or overmolded with the first and second integral valves 122,134. The first and second supports 180, 182 are snap fit into first andsecond recesses 186, 188, respectively, provided in the bases of thefirst and second housings 148, 150, respectively. In the illustratedembodiments, the supports 180, 182 are ring-shaped; however, as may berecognized by those of ordinary skill in the pertinent art, they maytake any of numerous different shapes and/or configurations that arecurrently known or later become known.

FIG. 4B is a cross-sectional view of the connector of FIG. 4A showingfull interconnection of the male and female connectors. As seen in FIG.4B, the first and second supports 180, 182 bolster the base of the firstand second integral valves 122, 134 and increase the structuralintegrity and durability of the connector 110 in the open position. Inthe open, interconnected position, the first and second supports 180,182 abut the integral valves 122, 134 to prevent failure of the valves.Another embodiment of the first and second supports 180, 182 is thatthey prevent the first and second integral valves 122, 134 from bendingor deforming beyond a maximum, open or deflected position.

The connectors of the present invention have numerous differentapplications in any of numerous different fields. For example, theconnectors may be used to interconnect IV tubing, pouches and tubing,filling tanks and/or filling machines, and any of numerous otherapplications requiring fluid connections. As can be readily appreciated,the connectors of the present invention are particularly well suited forapplications requiring an aseptic or sterile connection, or applicationsthat require the prevention of any contact with the fluid beingtransferred (such as a toxic fluid).

As may be recognized by those of ordinary skill in the pertinent artbased on the teachings herein, numerous changes, modifications andimprovements may be made to the above-described and other embodiments ofthe present invention without departing from the scope of the inventionas defined in the appended claims. For example, the ports, valves,engaging portions, deflecting members, connector bodies, connectorhousings and means for releasably or otherwise connecting theconnectors, may take any of numerous different configurations that arecurrently known, or that later become known. In addition, not allelements or all features disclosed herein are necessary, and if desired,additional elements or features may be added. Further, the elements orcomponents of the connectors may be made of any of numerous differentmaterials that are currently known, or that later become known. Stillfurther, the connectors may be used to transport any of numerousdifferent fluids that are currently known, or that later become known,such as drugs, pharmaceuticals, vaccines, ophthalmic products, creams,ointments, gels, beverages or food products, such as dairy, milk, cream,infant formula, chocolate, and industrial products, such as industrialliquids or gases. Still further, only one of the two connectors mayrequire a valve (e.g., if only one side of the connection need beaseptic or sterile), and thus one connector (male or female) may be aconventional connector or may different from the other connector.Accordingly, this detailed description of the currently preferredembodiments is to be taken in an illustrative, as opposed to a limitingsense.

1. An aseptic fluid connector comprising: a first connector including: afirst fluid passageway for receiving a fluid therein; a first port influid communication with the first fluid passageway for passage of thefluid therethrough; and a first deflecting member including a firstengaging portion radially spaced relative to the first port, and a firstvalve movable between a closed position and an open position withmovement of the first engaging portion between a substantiallynon-deflected position and a deflected position, respectively, whereinin the substantially non-deflected position the first valve is locatedin the closed position forming a fluid-tight seal between the firstvalve and first port and preventing the passage of fluid therethrough,and in the deflected position, the first valve is located in the openposition allowing the aseptic passage of fluid through the first port.2. An aseptic connector as defined in claim 1, further comprising: asecond connector connectable to the first connector and including: asecond fluid passageway for receiving a fluid therein; a second port influid communication with the second fluid passageway for passage of thefluid therethrough; a second deflecting member including a secondengaging portion radially spaced relative to the second port, and asecond valve movable between a closed position and an open position withmovement of the second engaging portion between a substantiallynon-deflected position and a deflected position, respectively, whereinin the substantially non-deflected position the second valve is locatedin the closed position forming a fluid-tight seal between the secondvalve and second port and preventing the passage of fluid therethrough,and in the deflected position, the second valve is located in the openposition allowing the passage of fluid through the second port.
 3. Anaseptic connector as defined in claim 2, wherein the first and secondconnectors are movable between non-connected and connected positions, inthe non-connected position the first and second engaging portions are inthe substantially non-deflected positions and the first and secondvalves are in the closed positions, and in the connected position, thefirst and second engaging portions are in the deflected positions andthe first and second valves are in the open position.
 4. An asepticconnector as defined in claim 1, wherein in the non-deflected position,the first valve forms a fluid-tight seal between the first port andambient atmosphere and prevents external contamination of anyfluid-contacting surfaces of the first port.
 5. An aseptic connector asdefined in claim 4, wherein the first connector further includes a firstbody defining a first sealing surface formed adjacent to the first port,and engageable with the first valve in the closed position to form afluid-tight seal between the first valve and first port.
 6. An asepticconnector as defined in claim 5, wherein the first sealing surface issubstantially annular, the first valve is substantially annular, and inthe closed position, the first valve engages the first sealing surfaceand forms an annular fluid-tight seal therebetween.
 7. An asepticconnector as defined in claim 6, wherein the first sealing surface isrelatively rigid, the first valve is, flexible, and in the closedposition, the first valve and first sealing surface form an interferencefit therebetween at the annular fluid-tight seal.
 8. An asepticconnector as defined in claim 6, wherein the first engaging portion isformed integral with the first valve, is radially spaced relative to thefirst valve, extends annularly about the first valve, and extendsaxially relative to the first valve.
 9. An aseptic connector as definedin claim 8, wherein the first engaging portion and first valve are madeof an elastic material.
 10. An aseptic connector as defined in claim 3,wherein the first connector further includes a first body defining afirst sealing surface formed adjacent to the first port, and engageablewith the first valve in the closed position to form a fluid-tight sealbetween the first valve and first port; the second connector furtherincludes a second body defining a second sealing surface formed adjacentto the second port, and engageable with the second valve in the closedposition to form a fluid-tight seal between the second valve and secondport.
 11. An aseptic connector as defined in claim 10, wherein in thenon-deflected position, the first valve forms a fluid-tight seal betweenthe first port and ambient atmosphere and prevents externalcontamination of any fluid-contacting surfaces of the first port, andthe second valve forms a fluid-tight seal between the second port andambient atmosphere and prevents external contamination of anyfluid-contacting surfaces of the second port.
 12. An aseptic connectoras defined in claim 11, wherein the first sealing surface issubstantially annular, the first valve is substantially annular, and inthe closed position, the first valve engages the first sealing surfaceand forms an annular fluid-tight seal therebetween; and the secondsealing surface is substantially annular, the second valve issubstantially annular, and in the closed position, the second valveengages the second sealing surface and forms an annular fluid-tight sealtherebetween.
 13. An aseptic connector as defined in claim 12, whereineach annular fluid-tight seal extends axially between the respectivevalve and sealing surface to further prevent the ingress of contaminantsthrough the seal.
 14. An aseptic connector as defined in claim 13,wherein the first sealing surface is relatively rigid, the first valveis flexible, and in the closed position, the first valve and firstsealing surface form an interference fit therebetween at the respectiveannular fluid-tight seal; and the second sealing surface is relativelyrigid, the second valve is flexible, and in the closed position, thesecond valve and second sealing surface form an interference fittherebetween at the respective annular fluid-tight seal.
 15. An asepticconnector as defined in claim 14, wherein the first engaging portion isformed integral with the first valve, is radially spaced relative to thefirst valve, extends annularly about the first valve, and extendsaxially relative to the first valve; and the second engaging portion isformed integral with the second valve, is radially spaced relative tothe second valve, extends annularly about the second valve, and extendsaxially relative to the second valve.
 16. An aseptic connector asdefined in claim 15, wherein each deflecting portion is substantiallydome shaped, and each valve extends laterally with respect to the axisof the respective dome-shaped deflecting portion.
 17. An asepticconnector as defined in claim 16, wherein each deflecting portion issubstantially cylindrical shaped, and each valve extends substantiallynormal to an axis of the respective substantially cylindrical-shapeddeflecting portion.
 18. An aseptic connector as defined in claim 15,wherein the first engaging portion and first valve are made of anelastic material, and the second engaging portion and second valve aremade of an elastic material.
 19. An aseptic connector as defined inclaim 16, wherein in the connected position, the first and secondengaging portions engage each other and deflect each other into thedeflected positions, and the first and second valves are invaginatedwithin the first and second engaging portions into their respective openpositions, the first and second ports are in fluid communication witheach other, and fluid is permitted to flow therebetween.
 20. An asepticconnector as defined in claim 3, wherein in the connected position, thefirst and second engaging portions form a substantially fluid-tight sealtherebetween.
 21. An aseptic connector as defined in claim 20, whereinin the connected position, the first and second engaging portions extendannularly about the first and second valves and the first and secondports, respectively, and form a substantially fluid-tight seal withrespect to ambient atmosphere.
 22. An aseptic connector as defined inclaim 21, wherein in the connected position, the first and second valvesextend annularly about the first and second ports, respectively, form asubstantially fluid-tight seal with respect to ambient atmosphere, andprevent contamination of any fluid-contacting surfaces of the first andsecond ports.
 23. An aseptic connector as defined in claim 3, whereinthe first connector is a female connector, and the second connector is amale connector that is received within the female connector in theconnected position.
 24. An aseptic connector as defined in claim 23,wherein the first connector includes a first connector housing thatextends annularly about the first engaging portion and the first valveand extends axially outwardly therefrom, and the second connectorincludes a second connector housing that extends annularly about thesecond engaging portion and the second valve and extends axiallyoutwardly therefrom, and is receivable within the first connectorhousing in the connected position.
 25. An aseptic connector as definedin claim 24, wherein in the connected position, the second connectorhousing is received within the first connector housing, and the firstand second engaging portions and the first and second valves, arelocated within the second connector housing.
 26. An aseptic connector asdefined in claim 25, wherein the first connector includes a first bodydefining the first port, the second connector includes a second bodydefining the second port, and in the closed position, a distal portionof the second body is received within a distal portion of the firstbody.
 27. An aseptic connector as defined in claim 26, wherein the firstconnector includes a plurality of first ports angularly spaced relativeto each other, and the second connector includes a plurality of secondports angularly spaced relative to each other.
 28. An aseptic connectoras defined in claim 3, further including a first fluid conduit connectedin fluid communication with the first connector, and a second fluidconduit connected in fluid communication with the second connector. 29.An aseptic connector comprising: first means for connecting including: afirst fluid passageway for receiving a fluid therein; second means influid communication with the first fluid passageway for passage of thefluid therethrough; and third means for deflecting including fourthmeans radially spaced relative to the second means for engaging anotherconnector and deflecting the third means, and fifth means movablebetween a (i) closed position for sealing the second means by forming afluid-tight seal between the fifth means and second means and forpreventing the passage of fluid therethrough and (ii) an open positionfor allowing fluid flow through the second means, wherein the fifthmeans is movable between the closed and open positions with movement ofthe fourth means between the substantially non-deflected position and adeflected position, respectively.
 30. An aseptic connector as defined inclaim 26, further comprising: sixth means for connecting including: asecond fluid passageway for receiving a fluid therein; seventh means influid communication with the second fluid passageway for passage of thefluid therethrough; and eighth means for deflecting including ninthmeans radially spaced relative to the seventh means for engaging anotherconnector and deflecting the eighth means, and tenth means movablebetween (i) a closed position for sealing the seventh means by forming afluid-tight seal between the tenth means and seventh means and forpreventing the passage of fluid therethrough and (ii) an open positionfor allowing fluid flow through the seventh means, wherein the tenthmeans is movable between the closed and open positions with movement ofthe ninth means between the substantially non-deflected position and adeflected position, respectively.
 31. An aseptic connector as defined inclaim 30, wherein first means is a first connector, the second means isa first port, the third means is a first deflecting member, the fourthmeans is a first engaging portion, the fifth means is a first valve, thesixth means is a second connector, the seventh means is a second port,the eighth means is a second deflecting member, the ninth means is asecond engaging portion, and the tenth means is a second valve.
 32. Amethod comprising the following steps: i. providing a first connectorincluding a first valve hermetically sealing in a normally closedposition a first port in fluid communication with a first fluidpassageway, and a sterile fluid in fluid communication with the firstfluid passageway; ii. connecting the first connector to a secondconnector including a second port in fluid communication with a secondfluid passageway; iii. during the connecting step, deflecting the firstvalve from the normally closed position to an open position, and placingthe first port in fluid communication with the second port; iv. allowinga flow of sterile fluid through the first and second ports; and v.during the preceding steps maintaining the first and second portshermetically sealed with respect to ambient atmosphere and therebypreventing contamination of any fluid-contacting surfaces of the firstand second ports and of the sterile fluid flowing therethrough.
 33. Amethod as defined in claim 32, wherein the first connector includes afirst valve and a first deflecting member, and the second connectorincludes a second valve and a second deflecting member, and thedeflecting step includes placing at least one of the first and seconddeflecting members into engagement with the other, deflecting the firstand second deflecting members and, in turn, moving the first and secondvalves from normally closed positions to open positions and placing thefirst and second ports in fluid communication with each other.
 34. Amethod as defined in claim 33, further comprising the step of forming afluid tight seal, when in the connected and open positions, between atleast one of (i) the first and second deflecting members, and (ii) thefirst and second valves, hermetically sealing the first and second portswith respect to ambient atmosphere, and preventing contamination of anyfluid-contacting surfaces of the first and second ports and of thesterile fluid flowing therethrough.
 35. A method as defined in claim 34,wherein during the connecting step, the first and second deflectingmembers resiliently engage each other and invaginate the first andsecond valves into the open position and into contact with each other toform an annular, fluid-tight seal therebetween.